Cleared Special

K172236 - Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

K172236 is an FDA 510(k) clearance for Pantheris Catheter (8F), manufactured by Avinger, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 97-day FDA review.

K172236 · Avinger, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
97d
Days
Class 2
Risk

K172236 is an FDA 510(k) clearance for the Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console.... Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 30, 2017 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172236

510(k) Number K172236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date October 30, 2017
Days to Decision 97 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K172236.
Straub Endovascular System
K172315 · Straub Medical AG · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K172687 · Spectranetics, Inc. · Nov 2017
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
K172386 · Volcano Atheromed, Inc. · Aug 2017
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
K170191 · Medtronic Vascular, Inc. · Jun 2017
Diamondback 360 Peripheral Orbital Atherectomy System
K170792 · Cardiovascular Systems, Inc. · Jun 2017
K172236 · Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
Download PDF FDA Summary Avinger, Inc.